COMMUNITY HERBAL MONOGRAPH ON
AVENA SATIVA
L., HERBA
To be specified for the individual finished product.
Well-established use
Traditional use
With regard to the registration application of
Article 16d(1) of Directive 2001/83/EC as
amended
Avena sativa
L., herba (oat herb)
aerial parts harvested before flowering –dried or
fresh.
i)
Herbal substance
Not applicable
ii)
Herbal preparations
-
Comminuted herbal substance
-
Liquid extract (1:4-6; ethanol 15-50% v/v)
-
Liquid extract (1:4-6; water).
iii)
Dry extracts corresponding to extracts
mentioned under ii)
iv) Expressed juice from the fresh herb
(1:0.64-0.80)
Well-established use
Traditional use
Herbal preparation in solid or liquid dosage form
or as herbal tea for oral use.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
1
The declaration of the active substance(s) for an individual finished product should be in accordance with
relevant herbal quality guidance.
©
EMEA 2008
2/5
4.1.
Therapeutic indications
Well-established use
Traditional use
Traditional herbal medicinal product for relief of
mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal
product for use in specified indications
exclusively based upon long-standing use.
4.2.
Posology and method of administration
Well-established use
Traditional use
Posology
Adolescents over 12 years of age, adults, elderly
Herbal preparations
Single dose
Comminuted herbal substance: 3 g for the
preparation of an infusion.
Liquid extract (1:4-6 ethanol 15-50% v/v): up to
5 ml up to 3 times daily
Liquid extract (1:4-6 water ): up to 5 ml up to
3 times daily
Other preparations corresponding to the daily
dose of 3 g dried herb.
Expressed juice from the fresh herb: 10 ml
3-4 times daily.
The use is not recommended in children under
12 years of age (see section 4.4 ‘Special warnings
and precautions for use’).
Duration of use
If the symptoms persist during the use of the
medicinal product, a doctor or a qualified health
care practitioner should be consulted.
Method of administration
Oral use.
©
EMEA 2008
3/5
4.3.
Contraindications
Well-established use
Traditional use
Hypersensitivity to the active substance.
4.4.
Special warnings and precautions for use
Well-established use
Traditional use
The use is not recommended in children under
12 years of age due to the lack of adequate data.
Caution is advised when used in patients with
coeliac disease because data on the protein
content are not available.
For liquid extracts containing ethanol, the
appropriate labelling for ethanol, taken from the
‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’,
must be included.
4.5.
Interactions with other medicinal products and other forms of interaction
Well-established use
Traditional use
None reported.
4.6.
Pregnancy and lactation
Well-established use
Traditional use
Safety during pregnancy and lactation has not
been established.
In the absence of sufficient data, the use during
pregnancy and lactation is not recommended.
4.7.
Effects on ability to drive and use machines
Well-established use
Traditional use
May impair ability to drive and use machines.
Affected patients should not drive or operate
machinery.
4.8.
Undesirable effects
Well-established use
Traditional use
None known.
If adverse reactions occur, a doctor or a qualified
health care practitioner should be consulted.
©
EMEA 2008
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Well-established use
Traditional use
No case of overdose has been reported.
5.1.
Pharmacodynamic properties
Well-established use
Traditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
5.2.
Pharmacokinetic properties
Well-established use
Traditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
5.3.
Preclinical safety data
Well-established use
Traditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended, unless
necessary for the safe use of the product.
Tests on reproductive toxicity, genotoxicity and
carcinogenicity have not been performed.
Well-established use
Traditional use
Not applicable.
4 September 2008
©
EMEA 2008
5/5
Assessment Report
I.
REGULATORY
MA: Marketing Authorisation;
TRAD: Traditional Use Registration;
Other TRA Other national Tr
Othe
STATUS OVERVIEW
1
r: If known, it should
D:
be spec
aditional systems of registration;
ified
or otherwise
add
’Not Known’
Mem
ber State
R
egul
atory S
tatu
s
Comments
2
Aust
ria
MA
TRAD
Other TRAD
Other Specify:
Belgium
MA
TRAD
Other TRAD
Other Specify:
Bulga
ria
MA
TRAD
Other TRAD
Other Specify:
Cyprus
MA
TRAD
Other TRAD
Other Specify:
Cze
ch Republic
MA
TRAD
Other TRAD
Other Specify:
Denm
ark
MA
TRAD
Other TRAD
Other Specify:
Esto
nia
MA
TRAD
Other TRAD
Other Specify:
Finlan
d
MA
TRAD
Other TRAD
Other Specify:
France
MA
TRAD
Other TRAD
Other Specify:
Ge
rmany
MA
TRAD
Other TRAD
Other Specify:
Gre
ece
MA
TRAD
Other TRAD
Other Specify:
Hungary
MA
TRAD
Other TRAD
Other Specify:
Iceland
MA
TRAD
Other TRAD
Other Specify:
Ireland
MA
TRAD
Other TRAD
Other Specify:
Italy
MA
TRAD
Other TRAD
Other Specify:
Latvi
a
MA
TRAD
Other TRAD
Other Specify:
Liec
htenstein
MA
TRAD
Other TRAD
Other Specify:
Lithu
ania
MA
TRAD
Other TRAD
Other Specify:
Luxemburg
MA
TRAD
Other TRAD
Other Specify:
Malta
MA
TRAD
Other TRAD
Other Specify:
The
Netherlands
MA
TRAD
Other TRAD
Other Specify:
Norw
ay
MA
TRAD
Other TRAD
Other Specify:
Poland
MA
TRAD
Other TRAD
Other Specify:
Portugal
MA
TRAD
Other TRAD
Other Specify:
Romania
MA
TRAD
Other TRAD
Other Specify:
Slovak Republic
MA
TRAD
Other TRAD
Other Specify:
Slovenia
MA
TRAD
Other TRAD
Other Specify:
Spain
MA
TRAD
Other TRAD
Other Specify:
Sweden
MA
TRAD
Other TRAD
Other Specify:
United Kingdom
MA
TRAD
Other TRAD
Other Specify:
1
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products
in the MSs concerned.
2
Not mandatory field
©
EMEA 2008
2/21
Assessment Report
Botanical species
Avena sativa
L.
Botanical family
Poaceae - Gramineae
Botanical synonyms
Avena orientalis
Schreb
.
,
Avena chinensis
(Fisch.) Döll.
Part of the plant
Fructu
s Avenae
Herba Avenae
e tical preparations
Herbal su
liquid dos
bstance or herbal preparations in solid or
age forms
Rapporteurs
Prof. Gert Laekeman
Prof. Arnold Vlietinck
©
EMEA 2008
3/21
and variety
Pharmac u
INDEX
REGULATORY STATUS OVERVIEW
ASSESSMENT REPORT FOR
AVENA SATIVA
HERBA AND
AVENA SAT
IVA
FRUCTUS
I.
Introduction
6
II.
Pharmacology
6
II.1. Phyto-chemical characterization
6
II.1.1.
Avena sativa
fruits
6
II.1.2
.
Avena sativa
green herb harvested before flowering
8
II.2. Absorption, metabolism and excretion
9
II.3. Pharmacodynamics
9
III.
Clinical efficacy
13
III.1 Dosage
13
III.2 Clinical studies
13
III.3. Traditional use
17
IV.
Safety
20
IV.1 Genotoxic and carcinoge
IV.1.1 Preclinical data
nic risk
20
20
IV.1.2. Clinical data
20
IV.2. Toxicity
20
IV.3 Contraindications
20
IV.4 Special warnings / precautions
20
IV.5 Undesirable effects
21
IV.6 Interactions
21
IV.7 verdose
21
V.
verall Conclusion
21
©
EMEA 2008
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I.
INTRODUCTION
This
fructus.
assessment report reviews the available scientific data for
Avena sativa
herba and
Avena sativa
In preparing this report, a number of data sources have been taken into account. Th
follows:
•
The results of a literature search carri
observation April 2007).
•
The Cochrane database (last observation June 2007)
e main ones are as
ed out using the available references in PubMed (last
•
Monographs included in the reference list.
•
Standard books on phytotherapy.
•
Internet sites on ‘Avena’, ‘phytotherapy’ and specific therapeutic applications.
ts and also herb, harvested before flowering (Hänsel et al. 1992). In
addition, some authors refer to use of the fresh plant just before harvest (Anand 1971; Bye et al. 1974).
II.
PHARMAC
OLOGY
II.1.
Phyto-chemical characterization
II. 1.1.
Avena sativa
fruits
Several fractions and substances have been described for the fruits of oats (Danie
List & Hörhammer 1972, Lasztity 1984, Krug 1985, Schneider 1985, Frølich & Ny
al. 2005; Bratt et al. 2003, Bryngelsson et al. 2002).
ls & Martin 1967,
man, 1988, Nie et
Sugar
fraction: mucilage (beta-glucan); 3 to 4% sugar (fructose, glucose),
Protein
fraction: contains glutelin (> 50%) and avenin . The globulin of oats fruits c
into an acidic (32,500 - 37,500 Dalton) and a basic part (22,00
protein exists as disulfide-linked alpha/beta species of molecular weight 53,000 to
considerable heterogeneity within both groups of polypeptides (Brinegar & Pet
protein fraction of oats contains more lysine as compared to other cereals. Endos
shells), embryonic axis and scutellum are rich in glutamic acid.
Various enzymes were identified, including alpha-amylase, phosphatase, tyrosinase,
lipase. From a practical point of view the lipases are the most important.
triglycerides is undesirable, due to t
ould be separated
0 - 24,000 Dalton). The unreduced
58,000. There is a
erson, 1982). The
perm, hulls (outer
he soapy and bitter flavours which can result.
maltase and
Hydrolysis of the
Lipid
fraction: the grains of oats contain the highest lipid fraction among all feeding crops belonging
to the family of the Poaceae. Unsaturated hydroxy fatty acids are formed by lipid peroxidase activity.
Avenothionin was identified as a viscotoxin-like purothionin low molecular weight lipoprotein. It
could be separated into alpha and beta avenothionin, of which the former had 47 amino acids.
Alkaloids
: The indole alkaloid
gramine is thought to be responsible for a weak sedative effect similar
to
Passiflora.
N
CH
3
N
CH
3
Figure 1: the alkaloid gramine
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EMEA 2008
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The plant is used for its frui
: (the latter up to
are described as
ich are not present
sulted in moderate
losses of avenanthramide Bp, while ferulic acid and vanillin increased. Avenanthramides Bc and Bf
were not affected by steaming.
OH
OH
H
O
OH
OR
OH
H
H
O
OH
CH
2
n
Figure 2: left: phenolic antioxidant, hydrolysed
, ferulic acid
Figure 3 Right:
in
and
O
O
O
O
-2c.
Figure 3: Vanillosid, a vanillin glycoside, reported to make the
aroma
of the seeds a
ttractive to horses.
The burned cinders (as) reported to contain 50 to 70
% silicon dioxide (SiO2
)
.
reen parts of the plant.
n properties, protecting the plant against mycoses. Also 3
isolated from
Avena sativa
herb. Figure 4. In
the known compounds a coniferyl alcohol moiety is linked to the flavone by an ether bond. In a new
d by C-C bonds (Wenzig et al. 2005).
en identified in the seeds and the g
flavonolignanes derived from the flavone, triticin, were
natural product, it is linke
Saponi
ns
may also protect oats against fungal infection
s. They are o
f the triterpene saponin type.
Steroids
i
n the seed
s like avenasterin and st
igmasterin.
Vitamin
s
: The seeds contain vitamins as indicated in t
he table below.
Table 1: Vitamin content of oats
Vitamin
content
reference
Vitamin A
Beta-carotene
Vitamin B1 / thiamine
Vitamin B6
Vitamin
0.862 mg/100g (mucilage)
< 1.0µg/100g (‘rolled’ oats)
3.89-7.07 mg/kg
56 nmol/g
l. 1989
, 1979
rtain, 1991
Barnes & Taylor, 1981
E / tocopherol
4,3 (alpha-T) – 0.5-1.0 (beta-T)
Cyanoglycosides:
Sprouts can contain the cyanoglycoside linamarin. The content declines during the
development of the plant (two leaves stadium only 10µM/100g).
Green oats contain mainly pectin and SiO
2
, esters with polyphenols and mono- or oligosaccharides.
These oligosaccharides can be incorporated in cellulose, facilitating the fixation of minerals. This
fixation can have negative effects, described as for instance the rachitogenic factor when calcium is
fixed in phytinic acid complexes from which dissociation is difficult. Fixation is also reported for
phosphates.
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Organic acids
: Diverse organic acids: malic, citric, malonic, aconitic, oxalic acid
0.04%). Caffeic and ferulic acid have antioxidant properties. Avenanthramides
polyphenols in oats seeds. The latter represents a group of phenolic compounds wh
in other cereal grains. Steaming and flaking of dehulled oat groats (inner kernel) re
equimolar proportions of caffeic acid
an aliphatic alcohol (R = Me or H).
avenanthramide
Flavonoids
: To date, 28 flavonoids have be
Rhamnosylisoswertisin may have phytoalexi
Bognar 1986
Heinoven et a
Jahn-Deesbach
Gregory & Sa
II. 1.2.
Avena sativa
green herb harvested before flowering
The composition of this part of the plant is described by Hänsel et al. (1992).
Sugar
fraction: beta-glucan, pentosans, saccharose, kestose, neokestose, bifurcose, neobifurcose and
the acid galactoarabinoxylan.
N-containing carboxylic acids
: avenic acid A and B.
O OH
O OH
O OH
O OH
O
OH
COOH
H
H
H
OH
H
H
H
OH
Figure 4: Avenic acid A
Figure 6: Avenic acid B
Saponins
: avenacoside A and B. These are glycosylated steroidal saponins. Leaves contain furostanol
saponins. Avenacosid content of leaves varies between 1-3 mg/g.
CH
3
O
beta-D-Glc
H
3
C
O
CH
3
CH
3
O
O
R
Figure 5: Avenacoside A and Avenacoside B.
Avenacoside A : R = βDGlc-[(4-1)Rha]-[(2-1)βDGlc]
Avenacoside B : R= βDGlc-[(4-1)Rha]-[(2-1)βDGlc-(3-1)βDGlc]
Flavonoids
: e.g. vitexin derivatives. See above under oat fruit.
OH OH
OMe
OMe
O
OH
H
O
OMe
OH O
Figure 6: tricin derivatives isolated from Avena sativa herb.
©
EMEA 2008
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Mineral substances
: see Table 2.
Table 2: Mineral content of fruits and green parts of
Avena sativa
(oats) (mg/100g)
Oats seeds
Green oats
K
Ca
355
79.6
129
342
3.7
5.8
1140
660
715
330
8.5
39
19.2
2.1
P
Mn
Fe
Zn
Cu
4.5
0.47
II.2
Absorption, metabolism and excretion
Bioavailability of avenanthramides, extracted from hull-less oats, was tested in hamsters.
with an ethanol: water (80:20) mixture and characterised with
lso detected with HPLC after oral gavage. Peak plasma concentrations
to 1.3% for both
n internal standard). Ferulic acid
had a bioavailability of 49.5% (Chen et al. 2004).
II.3.
Pharm
acodynamics
of pharmac d in the literature. Most of
the references are difficult to access (thesis, patents or poorly referenced documents).
ological activities describe
Table 3: Overview of literature data
regard
ing pharmacol gical activities
o
of
Avena sativa
Activity
Plant part / substance
Antibiotic effect (
in vitro
): fungi < 3µg/ml;
12.5µg/ml
Mycobacterium <
Antagonism of morph
Sap
onins: avenacin, avenacosid
ine (mice)
Antagonism of hypertensive effect caused by
Alcoho
lic (90%) extract of green oats
nicotin (rats)
Inhibition of prostaglandin
synthesis
Seeds extract hate buffer and alcohol
(96%)
cts (90%) of the aerial parts
Steroids
Polysaccharides from the seeds outer wall
Protein fraction
Tea of green oats
Phytic acid in fruits
with phosp
g cessation
Cholesterol lowering effect
Inhibition of plaque formation of teeth
Inhibition of protein synthesis
Lowering uric acid serum levels
Rachitis
Smokin
Alcoholic extra
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EMEA 2008
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Mg
The avenanthramides were extracted
HPLC. Plasma levels were a
were obtained after 40 minutes. Apparent relative bioavailability was limited
avenanthramide A and B (using 2’,3’,4’-trihydroxyacetophenone as a
Schneider (1985) gives an overview
Enhancing F
SH
Extract of leaves
Leaves
Dried herb
Polyphenols
Stimulating LH-f
ormation
Protection against gastro-intestinal ulcera
Anti-estrogenic effects
In vitro
Inhibitory activity on MAO-B
Extracts of
Avena sativa
herb, made with different ethanol concentrations were te
model. A commercially available enzyme preparation of MAO-B was used in a on
method in microtit
coupled reaction usinf N-acetyl-3,
1997).
More prominent inhibitions were obtained when the extracts were prepared with hig
of ethanol (mean + SD):
•
15% ethanol: 44.3 + 1.4 % inhibition
•
30% ethanol: 57.2 + 0.8% inhibition
•
50% ethanol: 78.6 + 0.4% inhi
These data were transmitted
sted in an
in vitro
e-step fluorimetric
er plates. The assay is based on the detection of H
2
O
2
in a horseradish peroxidase-
7-dihydroxyphenoxazine (Amplex red) (Zhou & Panchuk-Voloshina,
her concentrations
bition
on file and no further details on the way the extracts were prepared and the
way solvent controls were incorporated were given (Frutarom, data on file 2008). Also the number of
ase (e.g. rasagiline
elective for MAO-
assays per extract was not transmitted. MAO-B inhibitors are used in Parkinson’s dise
and selegiline). From the data transmitted it is not clear whether the inhibition was s
B, as no data for MAO-A were communicated.
Inhibitory activity on PDE-4 activity
The same extracts (see ‘
Inhibitory activity on MAO-B
’) were tested on phosphodie
The tests were done with an undifferentiated U937 human monocytic cell line. This
test the hormonal regulation of t
adding the beta-agonists and salb
PDE. PDE decreases the content o
in increased intracellular c-AMP levels. Residual c-AMP was quantitatively assessed
radioactivity corresponding with [
3
H]cAMP after separation by ion exchange column c
(Torphy et al. 1992).
Extracts p
SD):
•
15% ethanol: 35.3
+
3.3% inhibition
•
30% ethanol: 66.5
+
1.2% inhibition
•
50% ethanol: 89.5
+
2.4% inhibition
These data were transmitted on file and no further details on the way the extracts were prepared, the
number of assays and the way solvent controls were incorporated were given (Frutarom, data on file
2008). Inhibition of PDE-4 will result in higher intracellular c-AMP levels and can influence
neurotransmission. As from
in vitro
results it is very difficult to make any extrapolation to possible
effects
in vivo
.
sterase-4 (PDE-4).
cell line enabled to
he c-AMP. The c-AMP content could be temporarily increased by
utamol (cf. stimulation of adenylcyclase), followed by an increase in
f c-AMP by converting c-AMP to AMP. Inhibtion of PDE will result
by measuring the
hromatography
(mean
+
repared with higher concentrations of ethanol gave higher inhibitions of the PDE-4 activity
Assessor’s comments
Both series of experiments open interesting perspectives as a neurogenic activity of
Avena sativa
is
concerned. As these preliminary data are on company file, more work has to be done in order to gain
insight in the mechanisms of action exerted by
Avena sativa
extracts. None of the results has been
published in peer reviewed journals up to now.
©
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Anti-atherogenic activity
Avenanthramide-2c, a polyphenol from oat fruits, inhibits vascular smooth muscle ce
enhances nitric oxide production. There was a concentration dependent inhibition of t
³H thymidine in human vascular smooth muscle cells. Concentrations varied betwee
The effect was seen as an inhibition of proliferation of the vascular smooth muscle. Al
viable smooth muscle cells was significantly
washing out aventhramide-2c. Same concentrations of the compound stimulated the
a human endothelial cell line (P < 0.05) (Nie et al. 2005).
ll proliferation and
he incorporation of
n 40 and 120 µM.
so the number of
lowered (P < 0.05). The inhibition was reversible after
synthesis of NO in
The potential antiatherogenic activity of partially purified avenanthramides from o
evaluating their effects on adhesion of monocytes to human aortic endothelial
expression of adhesion molecules and production of proinflammatory cytokines and
endothelial cells. The avenanthramides were prepared by refluxing and pu
chromatography. The pre-incubation of HAEC with 4, 20 and 40 ng/ml avenan
mixture (AEM) for 24 hours significantly decreased adhesion of U937 monocytic c
1beta-stimulated HAEC. T
EAM at 20 and 40 µg/ml, but not at 4 µg/ml, for 24 hours significantly suppressed I
expressions of intracellular adhesion molecule-1, vascular cell adhesion molecule-1 and
the secretion of proinflammatory cytokines IL-6, chemokines IL-8 and monocyt
protein (MCP)-1 (Liu et al. 2004).
ats was tested by
cell monolayers,
chemokines by the
rified by column
thramide enriched
ells to interleukin-
he inhibition was concentration dependent. Pre-incubation of HAEC with
L-1beta-stimulated
E-selectine and
e chemoattractant
n after addition of
) added to the oat
phenolics synergistically extended the lag time for oxidation. The phenolics were extracted with
:20 v/v) (Chen et al. 2004). In general, avenanthramides showed a higher antioxidant
ydroxybenzoic
n the antioxidant
eic acid assay, oat samples showed a very
ethanol:water (80
level than each of the following typical cereal components: ferulic acid, gentisic acid, p-h
acid, protocatechuic acid, syringic acid, vanillic acid, vanillin and phytic acid. Whe
capacity during 28 days of storage was measured by the linol
good antioxidant activity (M
artinez-Tome et al. 2004).
Assessor’s comments
The recent investigations described above have mainly been carried ou
metabolites isolated from fruits. They cannot be considered as directly linked to the traditional uses of
t using secondary
Avena sativa
. Further
in vivo
clinical investigation needs to be undertaken.
Topical anti-inflammatory activity
Vasoactive intestinal peptide (VIP) was used as trigger to cause inflammation in
culture. Vasodilation was significantly increased after application of VIP. After treat
extract oligomer, the mean surface of dilated vessels and edema were significantly de
treatment with this extract decreased TNF-alpha (Boisnic et al. 2003).
human skin cell
ment with oatmeal
creased. Moreover,
ng Rhealba oat extract on human skin fibroblasts. Then a punch
re a multilayered
alysis of mitotic
neoepithelium in
comparison with untreated reconstituted skin over 22 days was evaluated histologically. On day 12,
16% of positive BrDu basal cells was detected after spray treatment in comparison with 4.2% positive
cells in untreated reconstituted skin (p < 0.05). During epidermal differentiation between days 12 and
22, a significant increase in the number of cellular epithelial layers after 16 and 18 days of spray
treatment was seen. Moreover the extension of re-epithelialization was also significantly increased after
spray treatment on days 16 and 18 (Boisnic 2005).
Aries et al. (2003 and 2005) found an inhibition by a colloidal extract of
Avena sativa
(Avena
Rhealba®) of the Ca-ionophore A23187 on the liberation of arachidonic acid from phospholipids and
the subsequent metabolism into prostaglandins and leukotrienes. The inhibition of the biosynthesis of
©
EMEA 2008
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There was a concentration-dependent increase in lag time for Cu
++
-induced oxidatio
oat phenolics to human LDL
in vitro
(0.52 to 1.95 µM). Ascorbic acid (2.5 and 5 µM
The same author tested a spray containi
biopsy as a source of epidermal cells was implanted on this dermal equivalent, whe
epidermis developed. Epidermal growth was evaluated by immunohistochemical an
activity (5-bromo-2'-deoxyuridine [BrDu] incorporation). The extension of the
prostacyclin (measured as 6-ketoPGF
1α
) was dose dependent. Also the expression
and COX-2 w
of phospholipase
as tempered. These findings open some perspective as anti-inflammatory activity in the
skin is concerned.
Cytokines represent a large series of regulatory proteins of the immunologic
produced by cutaneous cells during inflammatory processes. Examples are interleuk
IL5 and IL13) produced in atopic c
Avena stimulated the production of the anti-inflammatory TGFβ1 by keratinocytes
production of interleukins (Aries et al. 1999a).
system. They are
ins (e.g. IL2, IL4,
onditions, contact eczema and psoriasis. A colloidal extract of
and inhibited the
During cutaneous inflammation processes the neuro-immunocutaneous system is d
particularly an enha
nitric oxide (NO) is seen. The substance P mediated stimulation of NO synthesis
Avena flour preparation. An inhibition of the expression of NO-synthase is i
mechanism (Aries, 2000).
estabilized. More
nced production of neurologic mediators such as substance P and consequently
is blocked by an
dentified as basic
Aries (1999b) studied the activity
model. The expression of the Vascular Endothelial Growth Factor (VEGF) by human ker
the Boyden chamber was induced and augmented the migration of keratinocytes
contraction.
of Avena flour preparations on an experimental wound healing
atinocytes in
and collagen fibre
sor’s comments
se
in vitro
investigations are indicative of an anti-inflammatory activity of several oat fruit
e results can be considered to support the plausibility of the traditional topical use of
for dermatological conditions.
In vivo
Neurological activities
Non specific effects on brain activity were investigated after oral administration of Neuravena®
(EFLA®955 = standardised wild green oat extract, Frutarom Industries Ltd) to
information on the dose administered was not given). Oral gavage was continued
period. EEG was recorded during 5 hours using the ‘Tele-Stereo EEG’ methodology
obtained were suggestive stimulation of dopaminergic neurotransmission impli
functioning, motivation and depression. The results were in accordance with previo
M
rats (quantitative
over a 90 minute
. The brain pattern
cated in cognitive
usly
in vitro
seen
AO-B inhibitory activity (Frutarom data on file).
The effect of Neuravena® was also studied in behavioural trials. A group of 12 rats
a dose of 1g/kg body weight with their food over a period of 7 weeks. Another
tenfold dose and a control group received a normal diet. The results indica
abilities and alertness as well as improvement in general learning performance and
Moreover, a positive effect on social behaviour was observed. A subsequent patholo
also confirmed that Neuravena® was well tolerated in this subchronic treatment (
file).
was administered
group received a
ted enhanced stress coping
speed of learning.
gical examination
Frutarom data on
Assessor’s comments
To our knowledge the study of these neurological effects are a first approach to the traditional use of
Avena sativa
herb in different conditions related to stress. More investigations are welcomed and the
publication in peer reviewed journals of the data mentioned above are highly recommended.
Avena sativa
and
Amaranthus hypochondriacus
were used in a comparative study. Antioxidant
compounds were compared in both species (2 varieties of the latter were studied). Polyphenols,
anthocyanins, flavonoids and beta-carotene were present in higher concentrations in Avena as
compared to the Amaranthus species. Rats were fed with a basal diet or with basal diet to which 1%
cholesterol was added. The cholesterol fed rats received additionally 10% oats meal or 10% amaranth.
©
EMEA 2008
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Asses
The
preparations. Th
Avena sativa
Each experimental group consisted of 12 rats. Avena as well as amaranth kept
cholesterol and triglycerides lower as compared to the cholesterol-only group. HD
higher in the experimental groups as compared to the cholesterol-only group. The
sign
cholesterol, LDL-
L-cholesterol was
differences were
ificant and more outspoken for oats (P < 0.001) than for amaranth (P < 0.05) (Czerwinski et al.
The oral or parenteral oat beta-glucan treatment enhanced the resistance to
vermiformis
infect
induced a change in the lymphocyte population (Thy1.2+, CD4+, CD8) in the mesen
(Yun C.-H. et al. 2003).
S. aureus
and
E.
ion in mice. Beta-glucan increased the number of splenic IFN-γ-secreting cells and
teric lymph nodes
The cholesterol lowering p
that of barley in Syrian golden F
1
B hamsters fed with a cholesterol rich diet during 9 weeks (Delaney
et al. 2003).
otency of beta-glucan (2, 4 or 8 g/100g; n=8-9 per group) is comparable to
Assessor’s comments
These
in vivo
experiments are partially useful in the development of well established use indications.
h clinical trials preferentially done with standardised preparations of
III.
CLINICAL EFFICACY
III.1
Dosage
The following preparations have been used as traditional herbal medicines:
•
The mucilage of oat fruits is traditionally used without specification of an exa
ct dose.
Systemic use
•
Tincture of
Avena sativa
fresh herb: 3x 40 drops per day a
(Van Hellemont 1985).
re recommended
•
pecification. Most
bably it is made from Avena herb as most of the indications are referring to the central
nervous system.
•
The ‘Urtinktur’ (mother tincture) is made of fresh seeds (1/10) 100g, water 2
94.9 vol.% ad 1000ml. No dose is specified (List & Hörhammer, 1972).
33 ml and alcohol
•
The British Herbal Pharmacopoeia recommends a liquid extract of the se
alcohol: 0.6-2ml; and a tincture (1:5) in 45% alcohol: 0.2-5ml (Anonymus, 1
1992).
eds (1:1) in 25%
976; Hänsel et al.
•
The mother tincture of the fresh herb as described in HAB34 is mentioned (Schneider 1985).
•
In Germany a preparation called ‘Schoeneberger naturreiner Heilpflanzensaft Hafer’ is available
(Anonymus 2008)
•
According to some sources homeopathic preparations with the same tincture in potencies from
D3 to D200 can be used: 5-6 drops mixed with a spoonful of water can be used every half hour
in case of acute symptoms. Children between 6-12 years can use half of this dose (Anonymous
2007).
©
EMEA 2008
12/21
2004).
They should be coordinated wit
oats seeds.
Tincture of Avena is also mentioned by Madaus (1938), without any further s
pro
•
Of the herb harvested before flowering, one teaspoon (
+
3g) is mixed with 25
After cooling, the water is
0ml boiling water.
sieved from the mixture and taken several times a day as well as
before sleeping (Hänsel et al. 1992).
•
When used to influence smoking habits,
Avena sativa
fresh plant was se
harvest: 1.5 parts of the crushed whole (weight) plant in 5 parts of 90% ethy
kept at roo
1ml was diluted with 4
Bye et al. 1974).
lected just before
l alcohol (volume)
m temperature with frequent agitation for 72 hours and then filtered. Of this filtrate,
ml of water and this preparation was taken 4 times a day (Anand, 1971;
Cutaneous use
•
For a bath of 150 to 200 litres, 60g Avena flour is prescribed; for children 5
used.
0% of this dose is
•
Preparations of Avena seed flour are used. Colloidal ext
vehicle (e.g. petrolatume) in a concentration up to 20 to 30%
racts of flour are incorporated in a
.
•
‘Aveeno®’ products contain the colloidal extract in different forms:
0% of pure colloidal oatmeal.
-
‘Aveeno oatmeal®’: to be added to water for bathing.
-
‘Aveeno oilated®’: nonsensitising protective oil added to the oatmeal.
-
‘Aveeno ointment®’: Lassar paste with the starch component replaced by coll
oidal oatmeal.
•
Liquid paraffin with 5% oatmeal was used to treat burns.
•
of Avena sativa are prepared as ‘colloidal oatmeal’ described in the USP 30
0). It consists of the powder obtained by grinding the whole fruits, resulting in oat flour and
its of microbial contamination, water content, particle diameter
and ash composition are specified.
III.2
Clinical studies
Clinical trials
Open trials
Effect on uric acid excretion
Two studies have been conducted with a combination herbal product. There are no studies with Avena
containing
Avena
(herba 10%) and
The treatment period was 4 (n=21; mean age 58) or 8 (n=30; mean age
39) weeks. The posology was not reported. In both groups serum uric acid levels were lower at the end
of the treatment periods as compared to the initial levels: 8.87mg% versus 7.09mg% and 9.31mg%
versus 6;45mg% respectively (Krug 1985).
The same tea formula was compared in an open cross-over study with mineral water. Patients (n=20)
with asymptomatic hyperuricemia (6.5 to 10 mg%) were included. Patients took 6 cups of tea or
6 glasses of water additionally to the normal fluid intake. Treatment duration was 20 days. There was
one week wash-out period between both regimens. Purines were restricted during the study period. Uric
acid levels were lowered in both groups. The difference between treatment and controls did not reach
significance (P = 0.066) (Drisch 1988).
©
EMEA 2008
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-
‘Aveeno-bar®’: soap containing at least 5
Mostly fruits
(199
mixed with water. Viscosity, lim
preparations as a single component.
A group of 51 patients with elevated uric acid levels was treated with a tea formula
sativa
(green oats 75%),
Urtica dioica
(herba 10%),
Hypericum perforatum
Alchemilla alpine
(herba 5%).
Cutaneous use
Studies with single component oat preparations:
The effects of colloidal oatmeal derivates in daily use of some products for skin ca
After 3 months of treatment the cutaneous conditions improved according to
201/263 children. Parents
products was "very good" in 153/263 cases after 2 weeks of treatment and in 20
3 months (Camplone et al. 2004).
re on 300 children.
the physicians in
increased satisfaction level during the study as their judgement regarding the
1/263 cases after
Treatment with colloidal oatmeal was applied to 11 patients with a rash induced by ce
panitumumab and sorafenib. Of the 10 assessable patients, 6 had complete
responses, with no associat
effective in controlling the rash
kinase inhibitors. It allowed continuation of the antineoplastic treatment (Alexandresc
tuximab, erlotinib,
response and 4 partial
ed toxicities. Treatment with colloidal oatmeal lotion was considered to be
associated with epidermal growth factor positive cancers and tyrosine
u et al. 2007).
Studies with combination products:
The efficacy and tolerability was evaluated of a new lotion containing menthol and c
patients with itch and cutaneous xerosis (n=54). Patients treated with Aveeno Skin R
Loti
questionnaire revealed a significant improvement of cutaneous lesions including ery
scratching lesions, lichenization, and pruritus in 52 of 54 treated patients (96%). Comp
cutaneous lesions and pruritus was achieved in 48 of 54 (88.9%) patients; whereas a parti
was observed in 4/54 (7.4%) subjects and no improvement in 2/54 (3.7%) subjec
2005).
valuated of A-Derma Exomega cream in a total of Japanese 55 patients
n. A-Derma Exomega cream is a cosmetic emollient containing Avena Rhealba®
(Oat) total extract and evening primrose oil. After 4 weeks of topical application, skin dryness, scaling
sture content of the
concluded that the
ent in clinical application for the dry skin of atopic dermatitis, improving
and pruritus were reported to be greatly improved in almost all cases, and the moi
stratum corneum
was said to be increased significantly. The results of this study
product was safe and effici
patients' quality of life (Mizuno, 2005).
Randomized control trials
A number of studies have been conducted on various oat preparations. Some of th
foodstuffs such as oats cereals and oat bran enriched muffins. These studies are in
current research on oat preparations
e studies involved
cluded to illustrate
Effect on serum lipids
During an 11-week, randomized controlled trial, two groups of patients (Hispanic A
a corn cereal (n=79) or an oats-containing (n=73) cereal preparation. The main body
participants varied between 28.4 and 30.2 (patients with a BMI
>
38 were excluded).
At the end of the treatment period, total cholesterol in the oats group was 197.3 (
+
25.0) mg% (initial
value of 209.0
+
29.7 mg%). In the corn group total cholesterol did not change. The difference between
both groups was significant (P < 0.0003). The change was nearly entirely due to a lowering of the LDL
cholesterol as HDL cholesterol was not influenced (Karmally et al. 2005).
mericans) received
mass index of the
Following a 2 week run-in phase, 34 premenopausal women (22-53 years) were randomly assigned
either to a control group or to a treatment group, which received 2 oat bran-enriched muffins per day
(corresponding to 28 g/day) of oat bran) during 4 weeks. Compared to the control group (n=16) a mean
increase in plasma HDL-cholesterol of 11.2% was seen in women eating the oat bran supplement
(n=18) (P = 0.01). The total cholesterol decreased by 7.0% (P = 0.002). Results were similar after
adjustment for age, apo E genotype and weight change (Robitaille et al. 2005).
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olloidal oatmeal in
elief Moisturizing
on once daily for 3 weeks. After treatment, clinical examination, and the self-administered
thema, scaling,
lete regression of
al remission
ts (Pacifico et al.
The efficacy and safety was e
with atopic dry ski
Caloric restriction, fat modification and oat bran supplementation were part of the n
within a 4 week lifestyle health program for 235 patients with overweight and hypercholesterolemia.
Patients were divided into 2 groups: one lifestyle group (n=136) and another with the
als 35-50g oats per day (n=99). Male overweight but normocholesterolic subject
controls (n=55). In the
utritional regimen
same lifestyle but
s were selected as
oat bran enriched food group the most significant decreases in total cholesterol
were seen (- 67.7
+
37.2 mg%; p < 0.01). This decrease was mainly due to the influence on the LDL-
cholesterol (Berg et al. 2003).
percholesterolemic
the outcomes of
not differ between
pared to a group
r and beta-glucan
were incorporated into orange juice, LDL-cholesterol was significantly lower in the beta-glucan group
%
+
one week with 25 patients (18-65 years; BMI < 30; total cholesterol
(Kerckhoffs et al. 2003).
1.8%). The study was done in a parallel cross-over design, during
< 8 mmol/L)
Effect on blood flow and blood pressure
Brachial artery reactivity scans (BARS) were used to test the effect of oatmeal (60g
and E. The effect of acute (single dose) as well chronic (6 weeks) treatment was e
(16 males
>
35 years and 14 postmenopausal females) were treated in a randomized, placebo controlled,
double-blind, cross-over design with a 2 weeks wash-out period. Before measurement patients were
diated vasodilation
y significant when
reviously obtained
ith whole grain wheat cereal during one month (n=50; cross-over
) against vitamin C
valuated. Subjects
provoked by a high-fat meal (50g predominantly saturated). Oats increased flow me
measured as percent diameter change before and after treatment. This effect was onl
acute and chronic effects were pooled (Katz et al. 2004). The same results were p
when comparing whole grain oat w
design) Katz et al. 2001).
Month-long, daily supplementation with oat cereal may prevent postprandial impa
reactivity in response to a high-fat meal (50g predominantly saturated). Hyperemic
artery reactivity study (BARS) in the group of patients taking oatmeal or alph
irment of vascular
flow in a brachial
a-tocopherol was
maintained, whereas it was reduced
r antihypertensive
d for hypertension
rain oats-based or
. More participants in the oats group were able to stop or to reduce their
antihypertensive medication: 77% versus 42%. The oats group experienced a 24.2 mg% total
l reduction and a 15 mg% drop in plasma glucose versus controls (Pins et al. 2002).
cholestero
oats – 0.87 + 0.47
without oats. This
(BMI 26.4
+
3.3) participating in an 8 weeks study. Weight
reduction was comparable in both groups (oats – 3.9
+
1.6 kg versus control -4.0
+
1.1 kg) (Saltzman et
al. 2001; 131: 1465-1470).
olic blood pressure
Cutaneous use
A cutaneous irritation double blind study with 12 volunteers was conducted by Vié et al. (2002). The
participants were pretreated with 20 or 30% colloidal extracts in Petrolatume under occlusion during 2
hours. Control treatment consisted of Petrolatume. Sodium laurylsulfate was used as an irritant.
Irritation was evaluated from the redness of the skin and cutaneous blood flow. Avena protected the
skin from irritation as resulted from both parameters.
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The food matrix or the food processing, or both, could have adverse effects on the hy
properties of oat beta-glucan. This was the conclusion of a comparison between
2 studies with oat beta-glucan added to bread or to orange juice. LDL-cholesterol did
a group (n=23) eating bread and cookies with wheat fiber during 4 weeks, as com
eating bread and cookies with beta-glucan from oats (5 g/day). When the wheat fibe
(p < 0.001 for a decrease of 6.7
A diet containing soluble fibre-rich whole oats can significantly reduce the need fo
medication and improve blood pressure control. Men and women (n=88) being treate
with a mean baseline blood pressure below 160/100 were randomized to whole g
wheat-based cereals
A weight-loss diet containing oats was associated with favourable decreases in syst
(oats - 6
+
7 mmHg versus control – 1
+
10 mmHg; p = 0.026) and blood lipids (
mmol/L versus control – 0.34 + 0.5 mmol/L; p < 0.003) compared with a control diet
result came out of a study with 43 adults
in 35 acute burns
inst the vehiculum
e daily. Evaluation
was made assessor-blinded. The group using the oatmeal preparation scored better than the vehiculum
and required significantly less antihistamine medication (Matheson et al. 2001).
The corticoid sparing effect of a cutaneous oat extract was evaluated in children (n=1
old) with atopic dermatitis during 6 weeks. Children were randomly assigned to the
or to placebo. Utilisation of local corticoids, the Scoring Atopic Dermatits Index (S
quality of life of the infants (Infant’s Dermatitis Quality of Life Index) and
Impact) were used a
intervention group (P<0.05) vs. 7.5% in the control group. The SCORAD index, and infants’
parents’ quality of life significantly improved (P<0.0001) in both groups (Grimalt e
73 under 12 years
active preparation
CORAD) and the
parents (Dermatitis Family
s outcomes. There was a decrease of 42% of topical corticoid use in the
and
t al. 2007).
Assessor’s comments
Clinical trials with oats preparations are of relatively recent origin. The possible t
of oats in case of hypercholesterolemia and cardiovascular complications canno
being within the traditional usage. The data available are not yet sufficient to supp
Avena sativa
(fructus) in patients at cardiovascular risk; this aspect can be con
emerging science.
Although cutaneous use of
Avena sativa
has been studied in several open and
well established use cannot yet be accepted for several reasons. The patients in
trials vary widely as far as their pathological condition is concerned. Children
studied. Inclusion of atopic patients, patients with iatrogenic rash due to the admin
medicines, children who needed general skin care and patients with burns makes
well established indication difficult. The studies involved a range of different pro
sativa
ap
lotion. The duration of treatm
herapeutic benefits
t be considered as
ort the efficacy of
sidered as an
controlled trials, a
cluded in clinical
as well adults are
istration of several
the evaluation of a
ducts with
Avena
plied as an ointment or cream, oily liquid extract, colloidal oatmeal in liquid paraffin or as a
ent varied from 3 weeks to 10 months. Furthermore, the outcomes
measured were quite variable: remission of skin lesions, level of satisfaction, skin dryness with
ical measuring of the moisture content of the skin, patient discomfort, Scoring Atopic
ality of life. A well established use can only be accepted when
ment (process) and the measured outcomes (product) are
physicochem
Dermatitis Index (SCORAD) and qu
the inclusion criteria (patients), the treat
converging.
Use during pregnancy and lactation
No data available.
III.3.
Traditional use
It is not known from what age
Avena sativa
has been used medicinally. Most probabl
generated from Asia proxima. Cultivated oats are probably related to the spe
originating from
Europe. Hippocrates, Plinius the Old and Galenus recommended oats for its t
properties.
y the plant
cies
Avena fatua
,
the Mediterranean Sea region. Oats were already cultivated 4000 years ago in
onic and feeding
Hildegard von Bingen (12
th
century) describes the plant in her ‘Physica’:
… may everyone who is
exhausted with an empty mind take steam bath by poring water wherein oats have been cooked over
hot stone. If this treatment is repeated, the patient will get to himself again and regain the capacity of
thinking …
(
http://plantaardigheden.nl/plant/beschr/gonnve/haver.htm
The traditional use of
Avena sativa
extends over several therapeutic areas (Leclerc, 1947, List &
Hörhammer 1972; Madaus G Lehrbuch der biologischen Heilmittel 1938; Anonymus, British herbal
Pharmacopoea 1976; Schneider 1985, Schneider 1990).
©
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A comparison between 2 shower and baths oils was made during a 10 month period
patients. The active product contained liquid paraffin with 5% colloidal oatmeal aga
(liquid paraffin). Patients were asked to rate their discomfort from itch and pain twic
)
Rembertus Dodoneus (1608) mentioned
Avena sativa
as a useful treatment against bowel disorders
and as a diuretic.
Use as a sedative
The traditional use as a sedating agent is reported in a number of sources.
Madaus (1938)
… in der Amerikanischen Medizin findet eine Tinktur aus Hafer Verwendung als N
Chorea, Epilepsie, Insomnie, nervöser Erschöpfung, Alkoholismus und
Opiumentwöhnung. Allerdings wird die Wirksamkeit in letzterem Falle von
Beobachtern sterk bezweifelt ...
erventonikum bei
während der
sachverständigen
... The tincture of oats is used as a nervous tonic in the American medicinal practice in case of chorea,
rding to objective
epilepsy, insomnia, nervous exhaustion, alcoholism and opium detoxification. Acco
reviewers the efficacy for the
latter applications is doubtful …
List & Hörhammer (1972) mention the
use of oats (seeds) mother tincture:
… In der
Homöopathie bei
Neurasthenie und als Sedativum …
The British Herbal Pharmacopoeia (
in 25% alcohol and a tincture 1:5 in 45% alcohol.
•
Action: antidepressive, thymoleptic.
1976) and Hänsel et al. (1992) ,recommends the liquid extract 1:1
•
Indications: depression, melancholia, menopausal neurasthenia, general debility.
•
Specific indication: depressive states.
1985) recommends oats in case of nervous exhaustion, insomnia and nervous weakness.
For these indications the mother tincture of the fresh flowering plant is used (HAB34).
Van Elteren (2007) recommends
Avena sativa
in case of nervous irritation, depress
nervous exhaustion, nervous weakness, hysteria. The seeds as well as fresh oats are u
ion, sleeplessness,
sed.
Cutaneous use
External use is frequen
In t
tly mentioned in the concept document by Fabre (2004).
led inform
ation is given about traditional cutaneous use. References with* are
cited from Fab
re (2004
). In general there is an substantial tradition in Europe, in p
USA.
articular in France
and Germany, and the
Table 4: Traditional cutaneous use of Oats prepar
r)
ations
Author (yea
* Planchon G. & Col
Reported usage
lin E. ‘Emollient’ activity was menti
oned in ‘Les Drogues simples d’Origine
1895
Végétale’.
* Fournier P. 1947
Warm cataplasms of oats prepared with diluted acet
case muscle spas
with beer yeast is used on infec
ic acid are used in
ms and lumbago. A pasta made with oat’s flour mixed
ted ulcers and wounds, and to facilitate
cicatrisation.
The author reviews the dermatological use of oats.
8
* Hyde JK. 1900
* Leod Mac 1920
Oats can alleviate itching when used in baths.
Itching in case of erythema is cured with a preparation made of oat’s
flour.
The author used oat fruits to ‘soften’ the water in case of inflammatory
dermatological conditions.
* Ormsby OS. 1921
* Stockes JH. 1930
The author treated pruritus with oat mucilage.
* Andrews GC 1930
Oats alleviate dermatitis in patients suffering from acute chronic
dermatological exfoliative affections.
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Schneider (
he table below deta
i
* Laude B. 198
* Spinka J. 1939
Oats is mentioned as a
cataplasm for treatment of burnings.
n ingredient in baths and as a lotion, and as a
* Muscher
M. 1948
Author of a brevet on a preparation made from comminuted fruits,
omplex.
resulting in a protein-polysaccharide c
Dick LA. 19
58
Use of Avena as an emol
lient in pediatric dermatoses.
Franks AG. 195
8
Dermatological use of Avena in baths.
57
MonteBovi AJ. 1954
Use o
f Avena in the treatment of diaper rash.
Smith GC. 1958
The author makes an overview of coll
amongst them.
oidal demulcents with Avena
Avena mentioned in the treatment of various derma
toses.
There is a patent from 1944 (Anonymus, 1944) on a special oats fraction, relatively low in starch and
h in protein. The preparation is intended as an ingredient for cosmetics including hand
ness are desired.
Table 5: U
se for other purposes
These positive results could not be repeated in another clinical study (Anand 1971; B
Endocrinology
Should be useful in case of Premenstrual Syndrome (PMS) and depressions related to the menopausal
t: 1.5 parts of the
of opium addicts several patients reported a loss of interest in smoking.
ye et al. 1974).
status. Should also be an aphrodisiac for men as well as for women.
Oats can also lower the blood sugar with a positi
used to lower the amount of glucose.
External use
Water preparations of
Avena sativa
can be applied as a gauze in case of all kind of dermatological
(wet) eczema, skin infections and psoriasis. Can also be applied in case of burns and
ve effect on diabetes: in this case the mucilage is
problems like
itching.
External use is further mentioned as warm cataplasm in case of lumbago. Oats preparations should
relieve inflammations of the skin and should help cicatrisation.
Gastrointestinal tract
Avena sativa is used in case of diarrhea. It has a positive effect in liver func
complaints. Regular use of oats optimizes defecation.
The mucilage in case of gastro-enteritis and dyspepsia.
tion and stomach
General condition
The mucilage is used to sustain recovery in case of a serious disease and loss of appetite occurs.
Respiratory tract
In case of cough, gauze impregnated with an oats preparation should be applied on the throat. It is
used in case of respiratory infections.
Urinary tract
Since the 19
th
century Kneipp is a fervent promoter of the oats tea in case of rheumatic disease and
gout. The tea is still recommended as a diuretic. Leclerc (1947) provided an exhaustive list of
traditional applications of oats. They are among others related to urinary tract diseases.
©
EMEA 2008
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Leone F. 19
relatively ric
lotions, face creams, for baths or for application where a high viscosity and adhesive
Nervous system
When alcoholic extracts of
Avena sativa
(fresh plant selected just before harves
plant were used on a group
IV.
SAFETY
IV.1
Genotoxic and carcinogenic risk
No data available.
IV.1.1
Preclinica
l data
Mutagenicity and
carcinogenicity
No data available.
IV.
1.2.
Cli
nical data
No data av
ailable.
IV.2.
Toxicity
Acute toxicity
An avenathramide enrich
concentrations up to 40 µg/ml (Liu et al. 2004).
Irritation tests using colloidal extracts of Avena sativa revealed no ocular or cutaneo
was no sensitisation or photosensitisation seen. Concentrations of 2 to 100% were te
ed mixture did not show any cytotoxicity to human aortic endothelial cells in
us toxicity. There
sted (Fabre 2004).
Subchronic and chronic toxicity
data available on oral use.
cts are incorporated in different cosmetic formulations such as shampoo, soap,
ns and gels. These products have been available commercially since 1982.
These preparations are classified as well tolerated with cosmetovigilance index of < 0.2/10,000 units.
Reproductive toxicity
No data available
IV.3
Contraindications
The use of preparations containing Avena species is contraindicated for persons with a know
n
hypersensitivity to this plant.
IV.4
Special warnings / precautions
Cutaneous tolerance
Varjonen (1995) warned against cutaneous use of Avena preparations in atopic children, after
investigating the effects of these preparations in prick tests. Most probably the protein fraction (46 to
66 KD) was responsible.
Seven preparations were dermatologically tested in 114 patients suffering from atopic dermatitis and
115 patients with contact eczema: 3 preparations containing 3% of different total oats extracts in
petrolatum ointments or glycerolic solutions, 3 preparations containing 0.5% of different oats protein
fractions also in petrolatum ointments or glycerolic saline and pure petrolatum as a control. Evaluation
was made after 48 and 96 hours. In both dermatological conditions the frequency of allergic reactions
was reported as reduced. (El Bakali et al. 2000).
©
EMEA 2008
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There are no
Colloidal Avena extra
creams, ointments, emulsio
Similar results were obtained with a group of atopic children (n=202; age: from 1 m
A patch test with total oats extract (3%) or protein fraction (0.5%) in petrolatum and
sam
onth to 15 years).
prick test with the
e concentrations in glycerolic saline. Five children gave a positive reaction (= 2.4%) (Rancé
2001).
Systemic tolerance
A double blind multicenter study was performed to test tolerability of oats in 116 ch
diagnosed coeliac disease. During one year, one group received a standard gluten f
received wheat free oats (mean = 15g per day). Both groups did not differ signific
the study regarding coeliac serology markers or small bowel mucosal biopsies, incl
of intraepithelial lymphocytes (Högberg et al. 2004). Oats were well tolerated b
(n=18). The median daily intake of oats was 93g/day (range 27-137 g) during 6
(Storsrud et al. 2003). However, another study reported more intestinal symptoms
day; n=23) than with a traditional gluten free diet (n=16) in coeliac disease patien
oats suffered significantly more often from bowel complaints (diarrhoea and constip
structure did not differ between both groups, but the density of intraepithelial
slightly but significantly higher in the oats group. The levels of antibodies did not i
study period (Peraaho 2004). It should be noted that oats can be contaminated
atrophy and dramatic dermatitis were reported in a coeliac patient after a first and
with oats (Lundin et al. 2003). Up to 5 years of foll
eating a gluten free diet with or without
s t
oats group v
survey
tested and found to be
IV.5
ildren with newly
ree diet, the other
antly at the end of
uding the numbers
y coeliac patients
months to 2 years
with oats (50g per
ts. Patients taking
ation). The villous
lymphocytes was
ncrease during the
by wheat. Villous
second challenge
ow-up gave comparable results between a group
oats (n=92; randomly assigned to one of the treatments). This
dy has been contested because of the limited number of patients completing the study (n=23 in the
ersus n=28 in the control group) (Janatuinen et al. 2002; Dor & Shanahan, 2002). A
concluded to safe use. Coeliac patients should be advised to consume only those products
free from contamination (Thompson 2003).
Undesirable effects
No data available.
IV.6
No data available.
Interactions
No data available.
V.
OVERALL CONCLUSION
Avena sativa
L. has been known for more than 4000 years as a food and the tra
usage of
Avena sativa
has been documented since the 12
th
century.
ditional medicinal
The dried fruits have been used traditionally for the relief of various skin conditions as cutaneous
treatments, such as bath preparations, as colloidal extracts of oat flour mixed with a suitable vehicle or
as oatmeal in liquid paraffin.
The oat herb, harvested before flowering, has also been used traditionally as an herbal sedative usually
administered as a herbal tea, as aqueous or ethanolic extracts or as expressed juice from the fresh herb.
Recent studies with cutaneous preparations show some benefit in treating various skin conditions.
However, further evidence is needed from properly designed trials to substantiate the therapeutic
efficacy of the preparations tested.
©
EMEA 2008
20/21
IV.7
Similarly, recent investigations into the potential therapeutic effects of oat prepar
with hypercholesterolemia and cardiovascular complications are of inte
efficacy from properly designed clinical trials is needed to confirm the therapeutic e
ations on patients
rest but further evidence of
ffects.
The clinical data available do not support well established medicinal use of
Avena sativa
fruit or
Avena
sativa
herb.
On the basis of the traditional evidence, sufficient da
monographs for
Avena sativa
fruit and
Avena sativa
herb.
ta are available to develop Community herbal
The following traditional uses are supported by the bibliographic data:
Table 6 Traditi
onal uses for
Avena sativa
fruit and
Avena sativa
herb
Avena sativa
it
fru
atic treatment of
of the skin (such as sunburn) and as an aid in
healing minor wounds.
Avena sativa
herb
Traditional herbal medicinal product for the relief of mild symptoms
of mental stress and to aid sleep.
Avena sativa
fruit
There are no significant safety concerns with the use of the fruit preparations provide
by individuals who are hypersensitive to
Avena
species. Skin reactions may occur in
those with contact dermatitis.
d they are not used
atopic patients and
Avena sativa
herb
cerns with the use of the herb preparations provided they are not used
by individuals who are hypersensitive to
Avena
species. The usual precautions for herbal sedatives also
apply to
Avena
herb. In addition, caution should be advised in coeliac patients as data on possible protein
content are usually not available.
Genotoxicity data are not available for
Avena sativa
fruit and
Avena sativa
herb and thus entries to the
Community list are not possible at this time.
©
EMEA 2008
21/21
Traditional herbal medicinal product for the symptom
minor inflammations
There are no significant safety con
Source: European Medicines Agency
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